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Table 1 Preoperative demographics whole population

From: PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation

Factor

Whole study

On-X

SJM

p Value

Patients (N)

855

462

393

0.232*

Follow-up (ptyrs)

4078.0

2219.8

1858.3

 

Age (mean—SD)

49.0–12.6

49.2–12.7

48.9–12.4

0.728

Gender (N—% male)

503–58.8

287–62.1

216–55.0

0.036

NYHA (N—%)

 I

69–8.1

40–8.7

29–7.4

0.091

 II

298–34.8

154–33.3

144–36.6

 

 III

369–43.2

193–41.8

176–44.8

 

 IV

78–9.1

45–9.7

33–8.4

 

 Unknown

41–4.8

30–6.5

11–2.8

 

Etiology (N—%)

 Rheumatic

344–41.6

183–41.6

161–41.6

0.861

 Calcific

246–29.8

132–30.0

114–29.5

 

 Prosthetic Degeneration

20– 2.4

13–3.0

7–1.8

 

 Congenital

109–13.2

54–12.3

55–14.2

 

 Endocarditis

37–4.5

21–4.8

16–4.1

 

 Degenerative

56–6.8

30–6.8

26–6.7

 

 Other

15–1.8

7–1.6

8–2.1

 

Primary rhythm (N—%)

 Sinus

627–75.2

338–75.1

289–75.3

0.912

 Atrial fibrillation

193–23.1

105–23.3

88–22.9

 

 Paced

3–0.4

1–0.2

2–0.5

 

 Other

11–1.3

6–1.3

5–1.3

 

Aortic lesion (N—%)

 Stenosis

281–56.8

141–52.6

140–61.7

0.0499

 Regurgitation

82–16.6

42–15.7

40–17.6

 

 Mixed

130–26.3

84–31.3

46–20.3

 

 Other

2–0.4

1–0.4

1–0.4

 

Mitral lesion (N—%)

 Stenosis

80–23.2

49–26.5

31–19.4

0.224

 Regurgitation

68–19.7

35–18.9

33–20.6

 

 Mixed

195–56.5

99–53.5

96–60.0

 

 Other

2–0.6

2–1.1

0–0.0

 

Weight in kg (mean—SD)

73.2–22.1

74.2–22.5

72.0–21.6

0.147

Height in cm (mean—SD)

166.5–11.2

167.2–11.2

165.7–11.1

0.0504

Body surface area in m2 (mean—SD)

1.80–0.29

1.82–0.29

1.78–0.28

0.042

Body mass index in kg/m2 (mean—SD)

26.2–7.0

26.3–7.2

26.0–6.7

0.531

  1. p-value considered significant when < 0.05 and highlighted in those cases
  2. *Test for randomization across whole trial includes an adjustment from p = 0.5, because the Australian cohort was randomized 2:1 not 1:1 arriving at p = 0.48 for the trial